Identity
- Trade Name
- N Antisera to Human IgG FDA UDI
- Generic Name
- Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- Quantitative determination of IgG in human serum, plasma and CSF on BN Systems FDA UDI
- Model / Reference
- 10446297 FDA UDI
- Description
- Quantitative determination of IgG in human serum, plasma and CSF on BN Systems FDA UDI
Identifiers
- Catalog Number
- OSAS11 FDA UDI
- Primary DI / UDI-DI
- 00842768009785 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry
N Antisera to Human IgG by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetry.
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- Yumizen C1200 Immunoglobulin G — Horiba Abx · Class II
- Hevylite IgG Kappa Kit for Siemens BNII — The Binding Site Group · Class II
- Tinaquant IgG Gen2 — Roche Diagnostics Corp. · Class II
- Optilite Hevylite IgG Lambda Kit — The Binding Site Group · Class II
- Hevylite Human IgG Kappa Kit for use on the SPAPLUS — The Binding Site Group · Class II
- Hevylite Human IgG Lambda Kit for use on the SPAPLUS — The Binding Site Group · Class II
Cleared under the same submission
K083445 also covers:
K233663 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 82840ea7-70eb-4c40-85db-de1cec23c33a 37 fields · synced May 30, 2026